AKSHATHA VS

IQVIA

Bangalore

08.2024 - Current

Worked in various Studies as a Data Operations Co-ordinator(DOC) and as a reviewer in Therapeutic areas like Gastrointestinal, respiratory, Neurology, Oncology, psychiatry.
Drafted and reviewed the Study documents in Data Management Plan like Data Management Quality Plan(DMQP), Data Management Quality Control Plan (DMQCP) Completion Guidelines, Financial reports on monthly basis.
Perform the role of Data Reviewer and running query report from DB and working on answered queries, open queries and manual queries regularly to meet the query TAT.
Performed vendor data reconciliation with data acquisition and Performed SAE reconciliation.
Have a overview of the UAT environment.
Performed Query Quality Review (QQR) and Listings Quality Review (LQR) as Operations Lead and ensured to maintain the quality of the trial.
Supported the Studies by providing the Weekly or Monthly Status reports and managed to inform the team on the status of the study trial.
Understands how to raise Data Handling Entry, review and approval process.
Mentored the new resources and helped them in onboarding to the Study activities.
Successfully achieved database lock for 3 studies.
Received a Client recognition award, Bronze award and Ovation award
Was recognized and appreciated for the quality of data delivered directly from the sponsor team.